Genetic PredispositionNCT05975489
Genetics in the Effect of Caffeine on Fat Oxidation
A study testing Acute caffeine supplementation in people with Genetic Predisposition and Caffeine, run by Universidad Francisco de Vitoria at 1 site in Spain.
Trial summary
Genetic polymorphism on the effect of oral caffeine intake on fat oxidation during exercise has been studied in active and healthy population performing an incremental test on a cycle ergometer with 3-min stages at workloads from 30 to 70% of maximal oxygen uptake (VO2max). Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Genetic Predisposition, Caffeine, Fat Burn
- What is being tested?
- Acute caffeine supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2020to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- To be non-smokers. To have low caffeine intake (i.e., < 50 mg of caffeine per day in the previous 2 months) To show no previous history of cardiopulmonary diseases or having suffered musculoskeletal injuries in the previous 6 months.
Who cannot join
- To have VO2max values below 40 ml/kg/min To be sedentary
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of the Genetic Polymorphisms in the Effect of Caffeine on Fat Oxidation During Exercise
Genetic polymorphism on the effect of oral caffeine intake on fat oxidation during exercise has been studied in active and healthy population performing an incremental test on a cycle ergometer with 3-min stages at workloads from 30 to 70% of maximal oxygen uptake (VO2max). Participants performed this test after the ingestion of a) placebo; b) 3 mg/kg of caffeine; c) 6 mg/kg of caffeine. Fat oxidation rate during exercise was measured by indirect calorimetry. The influence of the CYP1A2 c.-163A>C, GSTP c.313A>G and PGC1a polymorphisms was evaluated to determine the effects on fat oxidation during exercise
Read the detailed description
Caffeine is a natural stimulant with well-recognized sports performance benefits. Aside its performance-enhancing effect, caffeine has the potential of increasing fat utilization during aerobic exercise at submaximal intensities, lowering-down the contribution of carbohydrate as a fuel. This property of caffeine may provoke a glycogen-sparing effect in the skeletal muscle and liver for exercise situations where carbohydrate availability may be a challenge. Additionally, the capacity of caffeine to enhance fat utilization during exercise could be of interest for improving health outcomes as it may increase the rate of change in body composition in exercise programs. Genetic factors like CYP1A2 c.-163A>C, GSTP c.313A>G and PGC1a c.1444G>A and C>T polymorphisms could be associated with the capacity for fat oxidation during exercise. To date, it is unknown if genetics increases fat oxidation and MFO in the same proportion during morning and evening exercise trials in women. For this reason, the aim of the present study was to evaluate the influence of the tCYP1A2, GSTP and PGC1a polymorphisms on the effect of caffeine on fat oxidation and MFO in active and healthy population. The authors hypothesised that genetics would increase fat oxidation and MFO during exercise and this effect would be of similar magnitude at several caffeine doses.
- Conditions
- Genetic Predisposition, Caffeine, Fat Burn
- Being tested
- Acute caffeine supplementation
- Medical subject headings
- Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute caffeine supplementationDietary supplement
To evaluate the influence of the time of the day (i.e., morning vs evening) on the effect of caffeine on maximal fat oxidation in women
| Study group | Role | What they receive |
|---|---|---|
| Caffeine 3mg/kg intake | Experimental | A dose of 3 mg/kg of caffeine (Bulk Powders, Essex, United Kingdom) was ingested before the beginning of each test. Receives: Dietary Supplement: Acute caffeine supplementation |
| Caffeine 6mg/kg intake | Experimental | A dose of 6 mg/kg of caffeine (Bulk Powders, Essex, United Kingdom) was ingested before the beginning of each test. Receives: Dietary Supplement: Acute caffeine supplementation |
| Placebo intake | Placebo comparator | A dose of 3 mg/kg of placebo (Cellulose, Guinama, Valencia, Spain) was ingested before the beginning of each test. Receives: Dietary Supplement: Acute caffeine supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genotype frequency of CYP1A2 polymorphism
Samples shall be obtained by swabbing and scraping of the buccal mucosa by the participant. The c.-163A>C (rs762551) polymorphism will be used.
Measured: Baseline
Genotype frequency of GSTP polymorphism
Samples shall be obtained by swabbing and scraping of the buccal mucosa by the participant. The c.1444G>A (rs8192678) and C>T (rs17650401) polymorphisms will be used.
Measured: Baseline
Genotype frequency of PGC1a polymorphisms
Samples shall be obtained by swabbing and scraping of the buccal mucosa by the participant. The c.313A>G (rs1695) polymorphism will be used.
Measured: Baseline
Secondary outcomes (4)
FATmax
The intensity of exercise that elicits MFO
Measured: 2-months
MFO
Maximal fat oxidation during exercise
Measured: 2-months
RPE
Rate of percevied exertion during exercise
Measured: 2-months
FAT and CHO oxidation
Fat and carbohydrates oxidation
Measured: 2-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Oct 2020
- Primary completion10 Feb 2021
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Genetic PredispositionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Francisco de Vitoria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Varillas Delgado, Principal investigator, Universidad Francisco de Vitoria, crta Pozuelo-Majadahonda km 1.800 PC 28223, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975489
- Sponsor's protocol ID
- UFV_genetic_caffeine
- Status last verified
- Jul 2022
- First submitted
- 27 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Varillas-Delgado D, Coso JD, Munoz A, Aguilar-Navarro M, Gutierrez-Hellin J. Influence of the CYP1A2 c.-163 A > C polymorphism in the effect of caffeine on fat oxidation during exercise: a pilot randomized, double-blind, crossover, placebo-controlled trial. Eur J Nutr. 2024 Oct;63(7):2697-2708. doi: 10.1007/s00394-024-03454-3. Epub 2024 Jul 15.
PubMed 39007997
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Genetic Polymorphisms in the Effect of Caffeine on Fat Oxidation During Exercise
- ClinicalTrials.gov ID
- NCT05975489
- Acronym / sponsor ID
- UFV_genetic_caffeine
- Conditions
- Genetic Predisposition, Caffeine, Fat Burn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidad Francisco de VitoriaUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Genetic polymorphism on the effect of oral caffeine intake on fat oxidation during exercise has been studied in active and healthy population performing an incremental test on a cycle ergometer with 3-min stages at workloads from 30 to 70% of maximal oxygen uptake (VO2max). Participants performed this test after the ingestion of a) placebo; b) 3 mg/kg of caffeine; c) 6 mg/kg of caffeine. Fat oxidation rate during exercise was measured by indirect calorimetry. The influence of the CYP1A2 c.-163A>C, GSTP c.313A>G and PGC1a polymorphisms was evaluated to determine the effects on fat oxidation during exercise
Detailed description
Caffeine is a natural stimulant with well-recognized sports performance benefits. Aside its performance-enhancing effect, caffeine has the potential of increasing fat utilization during aerobic exercise at submaximal intensities, lowering-down the contribution of carbohydrate as a fuel. This property of caffeine may provoke a glycogen-sparing effect in the skeletal muscle and liver for exercise situations where carbohydrate availability may be a challenge. Additionally, the capacity of caffeine to enhance fat utilization during exercise could be of interest for improving health outcomes as it may increase the rate of change in body composition in exercise programs. Genetic factors like CYP1A2 c.-163A>C, GSTP c.313A>G and PGC1a c.1444G>A and C>T polymorphisms could be associated with the capacity for fat oxidation during exercise. To date, it is unknown if genetics increases fat oxidation and MFO in the same proportion during morning and evening exercise trials in women. For this reason, the aim of the present study was to evaluate the influence of the tCYP1A2, GSTP and PGC1a polymorphisms on the effect of caffeine on fat oxidation and MFO in active and healthy population. The authors hypothesised that genetics would increase fat oxidation and MFO during exercise and this effect would be of similar magnitude at several caffeine doses.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Caffeine 3mg/kg intake | Experimental | Dietary Supplement: Acute caffeine supplementationA dose of 3 mg/kg of caffeine (Bulk Powders, Essex, United Kingdom) was ingested before the beginning of each test. |
| Caffeine 6mg/kg intake | Experimental | Dietary Supplement: Acute caffeine supplementationA dose of 6 mg/kg of caffeine (Bulk Powders, Essex, United Kingdom) was ingested before the beginning of each test. |
| Placebo intake | Placebo comparator | Dietary Supplement: Acute caffeine supplementationA dose of 3 mg/kg of placebo (Cellulose, Guinama, Valencia, Spain) was ingested before the beginning of each test. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- To be non-smokers. To have low caffeine intake (i.e., < 50 mg of caffeine per day in the previous 2 months) To show no previous history of cardiopulmonary diseases or having suffered musculoskeletal injuries in the previous 6 months.
Key exclusion criteria (1 listed)
- To have VO2max values below 40 ml/kg/min To be sedentary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute caffeine supplementationTo evaluate the influence of the time of the day (i.e., morning vs evening) on the effect of caffeine on maximal fat oxidation in women | Dietary supplement | Caffeine 3mg/kg intake, Caffeine 6mg/kg intake, Placebo intake |
Primary outcome
Genotype frequency of CYP1A2 polymorphism
Time frame: Baseline
Samples shall be obtained by swabbing and scraping of the buccal mucosa by the participant. The c.-163A>C (rs762551) polymorphism will be used.
Genotype frequency of GSTP polymorphism
Time frame: Baseline
Samples shall be obtained by swabbing and scraping of the buccal mucosa by the participant. The c.1444G>A (rs8192678) and C>T (rs17650401) polymorphisms will be used.
Genotype frequency of PGC1a polymorphisms
Time frame: Baseline
Samples shall be obtained by swabbing and scraping of the buccal mucosa by the participant. The c.313A>G (rs1695) polymorphism will be used.
4 secondary outcomes
FATmax
Time frame: 2-months
MFO
Time frame: 2-months
RPE
Time frame: 2-months
FAT and CHO oxidation
Time frame: 2-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Derived from this study: PubMed 39007997Varillas-Delgado D, Coso JD, Munoz A, Aguilar-Navarro M, Gutierrez-Hellin J. Influence of the CYP1A2 c.-163 A > C polymorphism in the effect of caffeine on fat oxidation during exercise: a pilot randomized, double-blind, crossover, placebo-controlled trial. Eur J Nutr. 2024 Oct;63(7):2697-2708. doi: 10.1007/s00394-024-03454-3. Epub 2024 Jul 15.
- Individual participant dataSharing planned: No
Related trials for Genetic Predisposition
RecruitingObservational study
Vascular Disease Discovery Protocol
Vascular Dysfunction, Genetic Mutations
RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Detection and Characterization of Infections and Infection Susceptibility
Immune Deficiencies
RecruitingObservational study
Clinical and Genetic Studies in Familial Non-medullary Thyroid Cancer
Non-Medullary Thyroid Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Varillas Delgado principal investigator
Universidad Francisco de Vitoria, crta Pozuelo-Majadahonda km 1.800 PC 28223, Madrid, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute caffeine supplementation in people with Genetic Predisposition and Caffeine, run by Universidad Francisco de Vitoria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genotype frequency of CYP1A2 polymorphism (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05975489, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.